A New Supplement for the "Metabolic Syndrome" | NCT03813914

Studies
A New Supplement for the "Metabolic Syndrome"

NCT03813914

Sponsor

University of Messina

Status

Completed

Last Update Posted

Jan 23, 2019Actual

Enrollment

60Actual

Phase

Not Applicable

Conditions

Metabolic Syndrome

Interventions

Sineos

Countries

Not provided

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jan 2019

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jan 15, 2017Actual

Primary Completion Date

Jan 15, 2018Actual

Completion Date

Jun 30, 2018Actual

First Submitted Date

Aug 7, 2018

First Submission Date that Met QC Criteria

Jan 21, 2019

First Posted Date

Jan 23, 2019Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jan 21, 2019

Last Update Posted Date

Jan 23, 2019Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Rosario D'anna, Principal Investigator, Clinical professor, University of MessinaPrincipal Investigator

Lead Sponsor

University of MessinaOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

This study evaluates the effect of a combination of glycirrhizic acid, Cinnamomun Zeylanicum and corosolic acid for the treatment of metabolic syndrome. Participants receive the supplement or a placebo.

Detailed Description

The supplement is composed by of a combination of glycirrhizic acid, Cinnamomun Zeylanicum and corosolic acid. They act in different way reducing insulin resistance, which is the main cause of metabolic syndrome. It was a randomized, controlled study involving 60 women with the metabolic syndrome following the criteria proposed by ATP III in 2015. Main outcomes were the improvement of the parameters that characterizes the metabolic syndrome, such as glucose and insulin levels, triglycerides, HDL-cholesterol and blood pressure.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

60Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Sineos	Experimental	Glycyrrhizic acid 38 mg + Cinnamomum Zeylanicum 150 mg + corosolic acid 480 mcg 2 pills/day for 3 months	Dietary Supplement: Sineos
Placebo comparator	Placebo Comparator	placebo 2 pills/day for 3 months	Dietary Supplement: Sineos

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Sineos	Dietary Supplement	glycyrrhizic acid 38 mg + Cinnamomum Zeylanicum 150 mg + corosolic acid 480 mcg 2 pills per day	Placebo comparator Sineos

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Changes in glycemia	Reduction of glycemia (mg/dl)	3 months
Changes in HDL-cholesterol	Increase of HDL-C (mg/dl)	3 months

Secondary Outcomes

Measure	Description	Time Frame
changes in HOMA-IR	measured as the ratio between glycaemia (mg/dl) and insulin (UI)	3 months
changes in total-cholesterol	reduction of cholesterol (mg/dl)

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria: Postmenopausal women affected by Metabolic Syndrome, diagnosed by ATP 2015 criteria.

Exclusion Criteria: treatment with steroids or with hypoglycemic or anti-cholesterol drugs

Accepts Healthy Volunteers

Sex

Female

Sex/Gender Based

Yes

Sex/Gender Description

Not provided

Minimum Age

45 Years

Maximum Age

65 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D024821	Metabolic Syndrome
D007333	Insulin Resistance

Ancestor Terms

ID	Term
D006946	Hyperinsulinism
D044882	Glucose Metabolism Disorders
D008659	Metabolic Diseases
D009750	Nutritional and Metabolic Diseases

Browse Leaves

Not provided

Browse Branches

Not provided